Biologics

Theratechnologies sBLA for HIV Drug Administration

Theratechnologies has submitted a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous (IV) push form of administration for treating, in combination with other antiretrovirals, human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults. The company recently announced results from the TMB-302 study, which it says demonstrated that there was no difference in pharmacokinetics between IV push and IV infusion.

Additionally, Theratechnologies says the study demonstrated that there were no serious adverse events observed and drug-related adverse events were considered mild to moderate. “Secondary endpoints were also achieved confirming no difference in HIV-1 viral load due to the change from IV infusion to IV push,” the company says. There were also no anti-Trogarzo antibodies or immunogenicity concerns, it adds.

Theratechnologies says that if approved Trogarzo IV Push would be a more convenient form of administration because it can be infused within 30 seconds without dilution compared to the 15-minute infusion time of the original IV infusion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome